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As the health care industry relies on the latest breakthroughs in technology, designing and manufacturing medical equipment is an increasingly regulated process. Dickinson Wright seamlessly combines regulatory, transactional, corporate finance, intellectual property, and litigation counsel for medical device developers, manufacturers, wholesalers, distributors, and technology companies newly entering the medical device market. We represent an extensive scope of business entities from start-ups to mid and large-sized companies as well as diversified global enterprises.
FDA Regulatory: With extensive experience helping clients navigate FDA regulations, Dickinson Wright’s lawyers offer regulatory counseling through every stage of product development and commercialization. From product classification and premarket strategy to submissions and aftermarket compliance, we counsel clients to promote efficiency and compliance throughout the product lifecycle.
In the premarket phase, we advise on regulatory and jurisdictional issues for devices and combination products, and formulate investigational device submissions and prepare and negotiate 510(k) and premarket approval applications. In the aftermarket phase, we assist with product modifications, medical device reporting, quality system regulation issues, recall, correction, removal and supply chain issues, labeling, advertising and promotion, and import and export issues. This includes Medicare and Medicaid coverage and reimbursement, and device compliance with state distribution and related laws. We prepare responses to FDA Form 483 observations and warning letters. We also represent device companies on all aspects of government sales, contracting, and disputes.
Transactional: Our lawyers regularly handle transactions involving product acquisitions and divestitures, negotiated business combinations by public and private companies, tender offers, proxy contests, restructurings, leveraged buyouts, and private transactions. Our financing transactions on behalf of device companies, venture capital, and private equity firms, and investment banks include senior secured credit facilities, acquisition financings, and refinancing.
Corporate Finance: The firm’s market-leading corporate, finance, and investment practices, and our strong contacts and presence in the global centers for finance and research, help us craft strategic capitalization solutions that connect companies with venture capital funds, investment and commercial banks, institutional lenders, and other investors. Our depth and scope in this division often involve us in multinational device development, manufacturing, licensing, and related transactions.
Intellectual Property: Our IP lawyers formulate and prosecute patent applications, including reexamination, reissue, and interference cases for medical device clients. Through the progress and commercialization of technology, we help clients effectively manage their rights, avoid infringement of third-party rights, and enforce patent rights against others. This includes negotiating and drafting patent and technology licensing agreements and enforcing and defending against patent infringement claims. We perform IP audits and due diligence investigations. Our lawyers also render opinions on patentability, infringement, and validity, and coordinate the filing and prosecution of patent applications in the United States and worldwide, particularly in Asia and Europe.
Litigation: Understanding that litigation is costly and time consuming and may damage an entity’s reputation, we proactively address issues and establish effective risk-avoidance strategies to avoid the courtroom. But, when action is necessary, our clients benefit from our creative and efficient approach to litigating disputes.